A Study of Simvastatin Metabolism as a Test for Celiac Disease Activity
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-007568
Sponsor Protocol Number: 15-007568
About this study
The purpose of the study is to assess the connection between simvastatin metabolism by an enzyme that varies based on the state of the small intestine in treated celiac disease.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Gluten-free diet for at least 1 year
- Clinical endoscopy within the past month
- Biopsies must show no villous atrophy or villous blunting
- Villous height to crypt depth (VHCD) ratio measurement should be 2.5:1 or greater
Exclusion Criteria
- Has a 1st degree relative with Celiac Disease
- Positive tTG IgA
- Already on simvastatin or statin agent
- Unable to stop non-steroidal or anti-inflammatory drugs
- Prior history of GI surgery other than appendectomy or cholecystectomy
- Taking drugs known to inhibit or activate CYP3A4
- Unable to avoid food known to inhibit CYP3A4
- History of a reaction to statin drugs in the past
- Pregnant or nursing
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Joseph Murray, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available